Tests DS9051b in adults with advanced adrenal cancer or advanced prostate cancer
Tests the safety of DS9051b in adults with advanced adrenal or prostate cancer.
Plain-language title generated from the registry record
Registry title: A Study of DS9051b in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resistant Prostate Cancer
Key facts
- Where
- Lille and Toulouse Cedex 9, FranceSee the 2 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or metastatic adrenocortical carcinoma, or with metastatic castration-resistant prostate cancer, to test the new drug DS9051b.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Advanced or metastatic adrenocortical carcinoma (ACC), or metastatic castration-resistant prostate cancer (mCRPC) with documented disease progression. Cancer must be confirmed by tissue examination. ECOG PS (daily activity level) of 0 or 1; 2 is accepted if it is due to cancer pain.
- Earlier treatment
- For prostate cancer: at least 1 line of ARPI therapy (for a minimum of 12 weeks in castration-resistant disease), and at least 1 line of chemotherapy, or not being able to have chemotherapy, or refusing it.
Main reasons for not taking part
- Pituitary gland dysfunction in the past
- Active or uncontrolled autoimmune disease needing systemic treatment
- Spinal cord compression or active brain or central nervous system metastases
- Uncontrolled or significant heart or blood vessel disease
- Cannot swallow whole tablets, or a gut disease or procedure that may affect drug absorption
Read by machine on 12 November 2026.
Where in France
- Centre Oscar LambretLille, FranceNo longer taking part
- Oncopole Claudius RegaudToulouse Cedex 9, FranceNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Daiichi Sankyo
- Trial code
- NCT07189403EU 2025-521886-28-00
- Record updated
- 22 May 2026
- Original description
This FIH study is designed to assess the safety, tolerability, and preliminary efficacy signals of DS9051b in participants with ACC and mCRPC.Read full original descriptionShow less
A Phase 1, First-in-human (FIH), Multicenter, Open-label Trial of DS9051b in Participants With Advanced or Metastatic Adrenocortical Carcinoma (ACC) and Metastatic Castration-resistant Prostate Cancer (mCRPC)
This FIH study is designed to assess the safety, tolerability, and preliminary efficacy signals of DS9051b in participants with ACC and mCRPC.
General Inclusion Criteria for All Participants; Sign and date the main ICF, prior to the start of any trial-specific procedures; Adults ≥18 years of age at the time the ICF is signed (Follow local regulatory requirements if the legal age of consent for trial participation is >18 years old); Histologically confirmed diagnosis of ACC or adenocarcinoma of the prostate; ECOG PS of 0 or 1 assessed no more than 14 days prior to C1D1. (ECOG PS of 2 due to cancer pain is acceptable); Has adequate organ and bone marrow function as assessed by local laboratory within 14 days prior to C1D1 as defined below. Organ and bone marrow function criteria must also be met when laboratory tests are repeated within 3 days of initiation of trial intervention as appropriate; Additional Inclusion Criteria for Participants with mCRPC; Treatment with at least 1 line (or more) of ARPI therapy for CSPC or in CRPC for a minimum of 12 weeks (eg, abiraterone, enzalutamide, darolutamide, apalutamide); Treatment with at least 1 line (or more) of chemotherapy, having ineligibility for chemotherapy or refusal of chemotherapy; Documented disease progression by one or more of the following criteria:; PSA progression as defined by PCWG3 criteria; Soft tissue disease progression as defined by RECIST 1.1 criteria; Bone disease progression as defined by Prostate Cancer Working Group 3 criteria; An individual who meets any of the following criteria will be excluded from participation in this trial:; History of pituitary gland dysfunction; Active or uncontrolled autoimmune disease requiring systemic treatment; Any medical condition (other than the cancer disease) requiring a dose of concurrent systemic corticosteroid treatment greater than 5 mg of prednisone and/or 100 μg of fludrocortisone per day (or equivalent); Active infection or other medical conditions that would make corticosteroids contraindicated; Has spinal cord compression or clinically active central nervous system metastases, defined as untreated, clinically progressive, symptomatic, or requiring systemic therapy with corticosteroids or anticonvulsants or local therapy (ie, radiotherapy) to control associated symptoms; Uncontrolled or significant cardiovascular disease; History of another primary malignancy (beyond the indication[s] under study) except for:; Malignancy treated with curative intent and with no known active disease ≥3 years before the first dose of trial intervention and of low potential risk for recurrence; Non-melanoma skin cancer, lentigo maligna, or lentigo maligna melanoma treated with curative intent and without evidence of disease; Carcinoma in situ treated with curative intent and without evidence of disease; Participants with a history of prostate cancer (tumor/node/metastasis stage) of Stage ≤T2cN0M0 without biochemical recurrence or progression and who, in the opinion of the investigator, are not deemed to require active intervention; Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE version 5.0, Grade ≤1 or baseline; Participants who cannot swallow whole DS9051b tablets and/or follow DS9051b administration schedule at protocol-defined frequency due to some reasons (eg, dysphagia etc); Known gastrointestinal disease or gastrointestinal procedure that may interfere with absorption of trial intervention including proton pump inhibitors and antacids.